Didodecyl 3,3'-thiodipropionate

Endpoint summary

Description of key information

OECD 401: LD50 >5000 mg/kg bw (no mortality)
OECD 402: LD50 >2000 mg/kg bw (no mortality)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-08-03, 1982-08-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline-study, but without GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, Sisseln, Switzerland
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 163 - 184 g
- Fasting period before study: overnight prior to dosing
- Housing: groups of 5 in Macrolon cages type 3 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin)
- Diet: NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Route of administration:

oral: gavage

Vehicle:

other: CMPS80

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (mortality and symptoms); on days 1, 7, 14, and at death (weight)
- Necropsy of survivors performed: yes

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasible, the LD50 including the 95 % confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed.

Mortality:

None.

Clinical signs:

other: Dyspnoea from day 1 to day 10; ruffled fur from day 1 to day 9; body position-curved from day 1 to 6. The animals recovered within 11 days.

Gross pathology:

No compound related gross organ changes were observed.

Table 1:Body Weights (g) and Standard Deviation

Dose (mg/kg bw)	Day 1	Day 7	Day 14
	Males
5000	179 (4.6)	231 (7.9)	271 (8.4)
	Females
5000	171 (7.4)	197 (7.9)	213 (12.1)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-04-28, 1992-07-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline-study performed under GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

84/449 EEC, B.3

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Animal Production, Stein, Switzerland
- Weight at study initiation: 217 - 240 g
- Housing: individually in Macrolon cages type 3, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France)
- Diet (ad libitum): NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland
- Water (ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: at least 10% of the body surface
- Type of wrap if used: gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily (mortality, signs, and symptoms); immediately before application and on days 7 and 14 (weight)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed.

Mortality:

None.

Clinical signs:

other: Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 days.

Gross pathology:

No deviations from normal morphology were found.

Table 1:Body Weights (g) and Standard Deviation

Dose (mg/kg bw)	Day 1	Day 7	Day 14
	Males
5000	234 (9.0)	265 (6.3)	296 (19.7)
	Females
5000	223 (6.2)	227 (12.5)	239 ( 13.9)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

> 2 000 mg/kg bw

Additional information

Acute oral toxicity

In the available CIBA-Geigy (No. 820894, 1982) study the acute toxic effects of the test substance was investigated after a single oral administration to rats. The investigations were performed in accordance with the OECD-Guideline 401 (Limit test). The test substance was administered once orally via gavage to 5 male and 5 female rats (Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif) suspended in CMPS80 (dose volume was 20 mL/kg bw) at a dose of 5000 mg/kg bw. Body weight and body weight gains were determined before administration, 7 and 14 days after the administration (p.a.); clinical observations were performed at least once per day during the 14 days observation period and all animals were sacrificed and necropsied 14 days p.a.. Dyspnoea, ruffled fur and curved body position were observed directly after treatment and lasted up to day 11 p.a.. The animals gained body weight as expected. No animal died and no compound related gross organ changes were observed. The oral LD50, was determined to be > 5000 mg/kg body weight.

 

Acute inhalation toxicity

No data available. Considering exposure conditions, inhalative intake of the substance is low, because it is a melting point solid that is produced in the form of granula.

 

Acute dermal toxicity

In the available CIBA-Geigy (No. 924056, 1992) acute dermal toxicity study conducted according to the OECD Guideline 402 (Limit Test), young adult Tif: RAI f (SPF)-rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the unchanged test substance (skin of the back, covered by semi occlusive dressing) for 24 hours. The application area corresponds to at least 10% of body surface area. The animals were observed for 14 days.

Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 days. The animals gained body weight as expected. No deviations from normal morphology were found. Since no mortality occurred, the acute dermal median lethal dose (LD50) was determined to be > 2000 mg/kg bw in rats.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.